Pharmacokinetics and Bioequivalence Study of Simvastation Tablet in Healthy Volunteers by LC-MS/MS Method

AIM To establish a LC-MS/MS method for the determination of simvastatin in human plasma,and to investigate the pharmacokinetics and bioequivalence of simvastatin tablet in Chinese healthy volunteers.METHODS 20 male healthy volunteers were randomized to receive a single crossover oral dose of simvastatin reference tablet or domestic tablet.The concentration of simvastatin in plasma was determined by LC-MS/MS.RESUALTS The simvastatin main pharmacokinetic parameters of test and reference tablets were as following: t_(max):(1.8±1.3) and(2.10±1.00) h,c_(max):(7.12±1.61) and(7.38±1.54) μg·L~(-1),AUC_((0-24 h)):(30.50±11.25) and(30.17±10.21) μg·L~(-1),t_(1/2):(3.90±0.78) and(3.76±0.85) h,F_((0-24 h)) was(101.2%±7.8%).CONCLUSION The assay was show to be sensitive,accurate,and the results were reliable.The test tablet was bioequivalent to the reference tablet.